Report: 2 thoroughbreds in Ocala, 2 in Kentucky die after being given compounded drug

By Carlos E. MedinaCorrespondent

Published: Sunday, May 18, 2014 at 4:17 p.m.

Last Modified: Sunday, May 18, 2014 at 4:17 p.m.

Compounded drugs are again in the spotlight after two thoroughbred horses in Ocala and two more in Kentucky reportedly died from complications after they were given a preparation to treat or prevent a protozoal infection.

This past week, a University a Florida veterinarian issued an alert about the compounded drug produced by Wickliffe Pharmacy in Lexington, Kentucky, after the death of two horses and neurological problems in six others at an Ocala training facility.

That was followed by a Food and Drug Administration alert on Thursday that documented the deaths of two other horses in Kentucky which were administered a similar preparation produced by Wickliffe.

The drug, toltrazuril/pyrimethamine, is used to treat or prevent equine protozoal myeloencephalitis or EPM. EPM affects the central nervous system in horses. It is transmitted through opossum waste which horses ingest while foraging or eating tainted feed.

Testing showed the amount of pyrimethamine in one lot of the drug was higher than what was listed on the label, according to the FDA release.

How much more of the drug was in the preparation was not released, but it was noted that high doses of pyrimethamine can cause seizures, fever and death. One of the Ocala horses died during a seizure. Four of the horses suffered repeated convulsions; one went down and was euthanized. The three others had mild convulsions.

In a statement, Wickliffe said it is “working cooperatively with federal health officials to learn more about the cause of the adverse events involving horses that received a compounded product from the pharmacy.” The pharmacy also extended its sympathies to the people connected with the stricken horses.

There is currently no FDA-approved drug containing toltrazuril and pyrimethamine for the treatment of EPM. Further, toltrazuril is not approved for use in horses.

However, compound pharmacies are allowed to make custom preparations of drugs with a doctor's or veterinarian's prescription.

There were two lots of the drug distributed. One was in paste form and the other in an oral suspension. All of the products in these lots were accounted for and are no longer in distribution, according to the FDA.

Critics of the compounding industry say the companies make large amounts of preparations at one time, like drug manufacturers. But the compounders do not need FDA approval for the drugs they make. The industry argues they are allowed to make drugs in anticipation of future prescriptions.

In its statement, Wickliffe said the medicine in question “was specifically made for and dispensed to the horses for which the medication was prescribed. No other animal patients received the prescribed medication in question.”

There have been several incidents involving compounded preparations, including in 2009, when Franck's veterinary division improperly mixed a nutritional supplement for 21 polo horses that contained far more selenium than required. The horses all died during a South Florida polo competition.

That incident prompted the Food and Drug Administration to try and stop Franck's from compounding veterinary medicine and supplements. Franck's eventually won the case in U.S. district court and continued to compound.

In 2012, Franck's was sold to a South Florida-based compounder after the pharmacy produced two eye preparations blamed for at least 33 cases of fungal infections in humans.

The investigation into the Wickliffe preparations is ongoing, according to the FDA. The pharmacy said it is “working cooperatively with federal health officials.”

“In general, FDA has serious concerns about unapproved animal drugs, including certain compounded animal drugs. These drugs are not evaluated by FDA and may not meet FDA's strict standards for safety and effectiveness. Unapproved animal drugs also may not be labeled or advertised appropriately,” according to the FDA statement.

<p>Compounded drugs are again in the spotlight after two thoroughbred horses in Ocala and two more in Kentucky reportedly died from complications after they were given a preparation to treat or prevent a protozoal infection.</p><p>This past week, a University a Florida veterinarian issued an alert about the compounded drug produced by Wickliffe Pharmacy in Lexington, Kentucky, after the death of two horses and neurological problems in six others at an Ocala training facility.</p><p>That was followed by a Food and Drug Administration alert on Thursday that documented the deaths of two other horses in Kentucky which were administered a similar preparation produced by Wickliffe.</p><p>The drug, toltrazuril/pyrimethamine, is used to treat or prevent equine protozoal myeloencephalitis or EPM. EPM affects the central nervous system in horses. It is transmitted through opossum waste which horses ingest while foraging or eating tainted feed.</p><p>Testing showed the amount of pyrimethamine in one lot of the drug was higher than what was listed on the label, according to the FDA release.</p><p>How much more of the drug was in the preparation was not released, but it was noted that high doses of pyrimethamine can cause seizures, fever and death. One of the Ocala horses died during a seizure. Four of the horses suffered repeated convulsions; one went down and was euthanized. The three others had mild convulsions.</p><p>In a statement, Wickliffe said it is “working cooperatively with federal health officials to learn more about the cause of the adverse events involving horses that received a compounded product from the pharmacy.” The pharmacy also extended its sympathies to the people connected with the stricken horses. </p><p>There is currently no FDA-approved drug containing toltrazuril and pyrimethamine for the treatment of EPM. Further, toltrazuril is not approved for use in horses.</p><p>However, compound pharmacies are allowed to make custom preparations of drugs with a doctor's or veterinarian's prescription.</p><p>There were two lots of the drug distributed. One was in paste form and the other in an oral suspension. All of the products in these lots were accounted for and are no longer in distribution, according to the FDA.</p><p>Critics of the compounding industry say the companies make large amounts of preparations at one time, like drug manufacturers. But the compounders do not need FDA approval for the drugs they make. The industry argues they are allowed to make drugs in anticipation of future prescriptions.</p><p>In its statement, Wickliffe said the medicine in question “was specifically made for and dispensed to the horses for which the medication was prescribed. No other animal patients received the prescribed medication in question.”</p><p>There have been several incidents involving compounded preparations, including in 2009, when Franck's veterinary division improperly mixed a nutritional supplement for 21 polo horses that contained far more selenium than required. The horses all died during a South Florida polo competition.</p><p>That incident prompted the Food and Drug Administration to try and stop Franck's from compounding veterinary medicine and supplements. Franck's eventually won the case in U.S. district court and continued to compound.</p><p>In 2012, Franck's was sold to a South Florida-based compounder after the pharmacy produced two eye preparations blamed for at least 33 cases of fungal infections in humans.</p><p>The investigation into the Wickliffe preparations is ongoing, according to the FDA. The pharmacy said it is “working cooperatively with federal health officials.”</p><p>“In general, FDA has serious concerns about unapproved animal drugs, including certain compounded animal drugs. These drugs are not evaluated by FDA and may not meet FDA's strict standards for safety and effectiveness. Unapproved animal drugs also may not be labeled or advertised appropriately,” according to the FDA statement.</p>